DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 20-39 are currently pending (claim set as filed on 1/30/2024). Claims 1-20 are cancelled. Claims 31-39 are withdrawn due to a restriction/election requirement. Claims 20-30 are under examination.
Election/Restrictions
Following a restriction/election requirement filed on 2/11/2026, claims 31-39 were withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method and kit, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/13/2026. The examiner called the attorney of record Adrian Hanlon on 5/15/2026 to offer to telephonically restrict after supplying a secondary reference. The attorney of record called back on 5/28/2026 to ask for a written restriction notice instead which was filed on 6/8/2026.
Following a restriction/election requirement filed on 6/8/2026, claims 31-39 were withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method and kit, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/30/2026.
Applicant's election with traverse of claims 20-30 in the reply filed on 7/30/2026 is acknowledged. The traversal is on the grounds that reference Abbas does not refer to reference Shlaes nor the multiantibiotic composition described therein, nor does it teach adding streptomycin and ciprofloxacin to a composition already comprising a plurality of antibiotics and thus this conclusion was achieved by hindsight. Applicant argues that one would not be motivated to combine the teachings of Abbas and Shlaes as Abbas teaches that combining streptomycin and cefotaxime may exhibit an antagonistic effect in some figures shown, and thus there is no expectation that one could expect a synergistic effect. The applicant argues that the claimed antibiotic combination provide several technical advantages that support the presence of an inventive step. Further, the applicant argues that there is no undue search burden on the examiner.
These arguments are not found persuasive. Reference Abbas does not need to mention reference Shlaes or its invention in Abba’s disclosure as it is the combination of references that establishes obviousness. Although the examiner concedes that the antibiotics in Abbas were not added to a multiantibiotic composition but to a singular one, Abbas still gives reason to add such antibiotics to a two or more antibiotic composition as it creates a synergistic effect (see Abbas pg. 1 – “Introduction”). Thus it would not be hindsight for the ordinary artisan to take the multiantibiotic composition as taught in Shlaes and find motivation to combine the antibiotics taught in Abbas with it, based off Abbas’s teachings that combining two or more antibiotics results in synergism. To address applicant’s argument that the combination of streptomycin and cefotaxime may result in antagonistic effects, this is rendered moot as cefotaxime is not the antibiotic claimed in the composition and thus how it interacts with streptomycin is not indicative of how it may result in synergism in combination with the claimed antibiotics in the composition. Next, the presence of technical advantages in the present invention that may provide evidence of inventiveness is to be addressed in the non-final office action and not in the restriction/election office action. Further, the claimed inventions of a composition, methods, and a kit would all require their own distinct prior art search using different CPC codes and search strategies, thus the applicant cannot prove that there would not be a serious search burden to examine all the claimed inventions.
The requirement is still deemed proper and is therefore made FINAL.
Claims 31-39 are withdrawn and claims 20-30 are under examination.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 21306063.5, filed on 7/30/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application. As no English translation has been provided, the effective filing date of this application is 1/30/2024.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/30/2024 and 2/28/2025 were considered, initialed, and attached herein. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The use of the terms “Harry Eagle's Minimal Essential Media (MEM), a-MEM, Basal Medium Eagle (BME), Glasgow's Minimal Essential Medium (G-MEM), Dulbecco's Modified Eagle Medium (DMEM), Ham's F-12, DMEM/F-12, Roswell Park Memorial Institute medium (RMPI 1640), Iscove's Modified Dulbecco's Medium (IMDM), Medium 199, Dulbecco's Phosphate Buffered Saline (D-PBS), and Hank's Balanced Salt Solution (HBSS)”, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 29-30 recite the limitation "amphotericin B". There is insufficient antecedent basis for this limitation in the claims. Further, it is unclear how the antibiotic composition can comprise a specific concentration of amphotericin B when it was not already established as being part of the aforementioned composition.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 20-27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Azevedo (Publication No. WO 2018/203315 A1 – date of publication 11/8/2018).
Azevedo’s general disclosure relates to determining susceptibility of microbes such as bacteria towards antimicrobial therapeutic agents (see [0007]).
Regarding claim 20, Azevedo teaches therapeutic agents against microbes comprising the antibiotics: penicillin (see [0020]), aminoglycosides such as streptomycin and gentamicin (see [0025]), fluoroquinolones such as ciprofloxacin (see [0024]), glycopeptides such as vancomycin (see [0026]), and combinations thereof (see [0020]). However, one would not immediately envisage the combination of antibiotics as claimed.
However, it would be obvious to one of ordinary skill in the art at the time of the effective filing date to combine the antibiotics as taught in Azevedo into one singular antibiotic composition. One would be motivated to do so because Azevedo suggests the individual antibiotics and combinations thereof in a therapeutic agent (see [0020 and 0024-0026]). Hence, the ordinary artisan would have found it prima facie obvious to combine the antibiotics as per Azevedo’s suggestion and it would have had a reasonable expectation of success in doing so.
Regarding claim 21, Azevedo teaches the antibiotic therapeutic agents were added to a microbial cell suspension (see [0009]) which was centrifuged, pelleted, and resuspended in cell culture broth (see [0055]).
Regarding claims 22-23, Azevedo teaches the cell culture broth can be supplemented with additives such as bovine calf serum from 0-10% (see [0055]). The prior art teaches that the cell culture broth can be further supplemented and the ordinary artisan would have found it obvious that the broth may include bovine calf serum or, alternatively, may be devoid of it.
Regarding claims 24-27 and 29-30, Azevedo teaches a polyene antibiotic therapeutic agent such as amphotericin B (see [0020 and 0031]). Azevedo also teaches these antibiotic therapeutic agents were administered in a final concentration at a range of 0.125-150 µM (see [0033]). The prior art teaches overlapping concentrations with the instant concentrations and it would have been obvious to the ordinary artisan to use the same amounts within the disclosed range. Although the disclosed prior art concentration range of 0.125-150 µM overlaps with the claimed concentrations, Azevedo does not teach the entirety of the claimed antibiotic concentrations.
It would be obvious to one of ordinary skill in the art at the time of the effective filing date to optimize the antibiotic therapeutic agents concentration as taught in Azevedo to the claimed ranges. One would be motivated to do so because Azevedo teaches that the antibiotic therapeutic agent concentrations can be manipulated to increase their range to determine minimal inhibitory concentrations (see [0071]). Thus the ordinary artisan would have found it obvious to modify the antibiotic concentrations as desired to arrive at the claimed concentration ranges and would have only required routine experimentation to do so.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Azevedo (Publication No. WO 2018/203315 A1 – date of publication 11/8/2018) and further in view of Pirlar (Pirlar et al., “Combinatorial effects of antibiotics and enzymes against dual-species Staphylococcus aureus and Pseudomonas aeruginosa biofilms in the wound-like medium”, 2020 Jun 25, Plos One, 15(6), pgs. 1-19).
Azevedo’s general disclosure has been set forth above.
Regarding claim 28, Azevedo teaches therapeutic agents against microbes comprising the antibiotics: penicillin (see [0020]), aminoglycosides such as streptomycin and gentamicin (see [0025]), fluoroquinolones such as ciprofloxacin (see [0024]), glycopeptides such as vancomycin (see [0026]), and combinations thereof (see [0020]).
However, Azevedo does not teach the composition further comprises an enzyme.
Pirlar’s general disclosure relates to the synergistic effect of antibiotics and enzymes such as trypsin against bacterial biofilms and the ability of enzymes to enhance the effectiveness of antibiotics (see abstract and pg. 10, ¶ 1).
Regarding claim 28, Pirlar teaches an multi-antibiotic composition of amikacin and meropenem in conjunction with an enzyme solution of DNAse I and trypsin (see pg. 6, ¶ 1), which are tissue dissociation enzymes.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add an enzyme as taught in Pirlar to the antibiotic therapeutic agents as taught in Azevedo. One would be motivated to do so because Pirlar teaches the enzymatic treatment can disrupt bacterial biofilms such as Staphylococcus aureus and furthermore can increase the effectiveness of antibiotics, specifically gentamicin (see Pirlar pg. 10, ¶ 1). This would be an advantage to Azevedo’s disclosure which uses an antibiotic therapeutic agent, of which gentamicin is exemplified (see Azevedo [0025]), to disrupt bacterial species such as Staphylococcus spp. (see Azevedo [0019]).
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.R.W./Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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